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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05558605




Registration number
NCT05558605
Ethics application status
Date submitted
11/09/2022
Date registered
28/09/2022

Titles & IDs
Public title
Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment
Scientific title
Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment
Secondary ID [1] 0 0
325-22
Universal Trial Number (UTN)
Trial acronym
AGILE-Echo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Valve Heart Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - AI-guided echo
Diagnosis / Prognosis - Standard echo

Experimental: Screening/Management Plan - AI-guided echo acquisition performed using a desktop echo machine (uSmart 3300, Terason, Burlington, MA) with AI software (Caption Health, Brisbane, CA) obtained by a non-expert (eg. clinic nurse, registrar general practitioner or physician) at the remote clinic, usually on the day of clinic review. Images will then be uploaded onto a secure cloud and downloaded at the core lab for measurement, interpretation and reporting.

Active comparator: Usual care - Standard echo acquisition by a sonographer either at a referral hospital, or by a visiting team - usually necessitating a delay. Measurement, interpretation and reporting will happen as usual.


Diagnosis / Prognosis: AI-guided echo
AI-guided echocardiography

Diagnosis / Prognosis: Standard echo
Standard echocardiography
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Diagnosis of cardiac dysfunction or heart valve disease
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
* Age >45 years
* eligible for Medicare
* exercise intolerance or cardiovascular (CV) risk factors
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known HF or HVD
* situations where cardio-protection is already indicated (eg. known CAD)
* comorbid conditions with life expectancy <2 years
* inability to provide written informed consent

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
612
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Alice Springs Hospital - Alice Springs
Recruitment postcode(s) [1] 0 0
- Alice Springs

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Alice Springs Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Princess Alexandra Hospital, Brisbane, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Royal Perth Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Ochre Health
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Walgett Aboriginal Medical Services
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Merriden Health Service
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Government body
Name [7] 0 0
Royal Hobart Hospital
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tom Marwick, MBBS, PhD
Address 0 0
Baker Heart and Diabetes Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tom Marwick, MBBS, PhD
Address 0 0
Country 0 0
Phone 0 0
+61385321550
Fax 0 0
Email 0 0
tom.marwick@baker.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05558605